AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K112235
Device Name AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
Applicant
AIRSTRIP TECHNOLOGIES, LP
3303 oakwell ct., suite 200
san antonio, 
TX 
78218

Applicant Contact andy miller
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 08/04/2011
Decision Date 08/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No